Interest of Self-compression Technique on Tolerance of Mammography (ITACTs)

Institut de Cancérologie de Lorraine

Status: Completed

Conditions: Breast Cancer

Treatments: Other: questionary; Other: mammography according to a standard procedure; Other: mammography according to an auto-compression procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT02866591

2012-A00248-35

Details and patient eligibility

About

Mammography is used for screening, diagnosis, therapeutic evaluation and monitoring of local cancer breast.

It is sometimes poorly tolerated by some patients who complain of an uncomfortable examination or pain.

Breast compression by the manipulator aims to reduce the thickness of the breast during mammography; This act is an important factor of pain or discomfort felt by the patient. But, it is also an image quality factor.

This study aimed to compare self-breast compression by the patient to the compression standard technique carried out by the manipulator.

Enrollment: 550 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients ≥ 18 years and ≤ 75 years of age
• ECOG performance <2
• Mammography planned as part of a breast cancer screening or a monitoring following treatment of a breast lesion
• Ability to provide written informed consent
• Patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study.

Exclusion criteria

• Eastern Cooperative Oncology Group performance status ≥ 2
• Treatment for benign lesion with surgery for less than 3 years
• Treatment for cancer with surgery and / or radiotherapy for less than 3 years
• Biopsy for less than 1 year
• Breast prosthesis
• Mastectomy
• Assessment motivated by a clinical breast abnormality

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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550 participants in 2 patient groups

Arm A

Experimental group

Description:

Patients have a mammography performed by themselves according to auto-compression procedure. The radiologist leads the compression at a minimum threshold of 40 Newton, then leaves the control of the compression to the patient. The radiologist treats only the positioning of the breast on the sensor.

Treatment:

Other: questionary

Other: mammography according to an auto-compression procedure

Arm B

Active Comparator group

Description:

Patients have a mammography performed by the radiologist according to standard procedure.

Treatment:

Other: questionary

Other: mammography according to a standard procedure